Sway System Sports Plus

Sway System Sports Plus is a software application for Apple iOS and Android mobile devices that provides computerized cognitive assessment to aid in the evaluation and management of concussion in individuals aged 18-24. It administers a battery of cognitive tests (reaction time, impulse control, inspection time, and memory) plus balance assessment and symptom tracking, displaying results via mobile app, web portal, and PDF reports. The device is not intended as a standalone diagnostic tool but rather to measure cognitive function changes in suspected concussion cases.

Sway Sports+ operates on mobile devices (iOS and Android) using built-in accelerometer, gyroscope, and touch-screen input, whereas the predicate ImPACT QT runs on iOS devices via touch input only, and the reference ImPACT uses desktop/laptop computers with external peripherals. All three are stand-alone software applications that administer neurocognitive test batteries and record objective performance measurements. Sway Sports+ differs in cognitive task content and design but shares the same fundamental technology of presenting stimuli on-screen and capturing response signals to measure cognitive performance.

ISO 14971 (risk management), IEC 62304 (medical device software lifecycle), and IEC 62366 (usability engineering). Software was tested per internal verification and validation protocols to ensure compliance with product requirements, including usability validation testing.

The intended use is identical to the predicate device (cognitive assessment aid for concussion management), and the patient age range for Sway Sports+ (18-24) is contained within the predicate's range (12-70). Although cognitive task content and input methods differ, both devices employ the same fundamental technology of administering neuropsychological tests on mobile platforms and recording objective cognitive performance measurements. Clinical validity studies demonstrate that Sway Sports+ shows similar construct validity (r = 0.22–0.42) and test-retest reliability (ICC = 0.68–0.92) comparable to predicate devices, with sensitivity of 69.6% for detecting concussion that is not significantly different from ImPACT's 58.7%. The differences in task design, input methods, and operating systems do not affect safety or effectiveness for the intended use.